Biotech Values

[DewDiligence]

GENZ provides Myozyme update. The PDUFA date for the BLA relating to the second production site is 11/29/08.
Unfortunately for investors, the portion of the advisory
panel meeting on 10/21/08 that deals with manufacturing with be closed to the public.

http://biz.yahoo.com/bw/080923/20080923006223.html

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The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will meet on October 21, 2008, to discuss the company’s BLA, as required by the FDA Amendments Act for all new drug and biologic license applications.

Genzyme currently has U.S. approval for Myozyme manufactured at the 160L bioreactor scale. FDA approval of 2000L-scale production is needed to provide broader access to treatment for adult patients in the United States. The agency views alglucosidase alfa manufactured at the 2000L scale as a separate product because of differences in its carbohydrate structure and has required Genzyme to submit a separate BLA.

The first portion of the October 21 advisory committee meeting will focus on proprietary manufacturing data and will be closed to the public. The second portion of the advisory meeting will be open to the public and will focus on clinical data from Genzyme’s Late-Onset Treatment Study (LOTS), which will be the basis for the approval of the proposed labeled indication for the new scale product. This study, which met its co-primary efficacy endpoints, evaluated the safety and efficacy of Myozyme in adult patients with Pompe disease.

FDA and Genzyme briefing documents for the advisory committee, along with the agency’s questions for the panel, are expected to be posted on the FDA’s web site at least two business days before the meeting. Genzyme anticipates that the FDA review process will culminate in the availability of two commercial versions of alglucosidase alfa in the United States: one produced at the 160L scale and the other produced at the 2000L scale.
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